Device Classification Name |
standard polysomnograph with electroencephalograph
|
510(k) Number |
K971867 |
Device Name |
ALICE 4R SYSTEM |
Applicant |
HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE |
MARIETTA,
GA
30067
|
|
Applicant Contact |
TIMOTHY Y COWART |
Correspondent |
HEALTHDYNE TECHNOLOGIES, INC. |
1850 PARKWAY PLACE |
MARIETTA,
GA
30067
|
|
Correspondent Contact |
TIMOTHY Y COWART |
Regulation Number | 882.1400
|
Classification Product Code |
|
Date Received | 05/20/1997 |
Decision Date | 08/13/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|